The Gardasil Vaccine – Introduction to a Series

As the nation’s attention is riveted on the discourse about healthcare reform, another debate is taking place. Ironically, it crisscrosses with elements found in the larger conversation. These include the right of American women – regardless of income – to have accessible health care, the role of pharmaceutical companies in the healthcare equation, parental rights, informed consent, and the influence of lobbies. Add in the issue of teenage sexuality, and you have a confluence of factors contributing to the groundswell of dialogue taking place around the Gardasil vaccine developed by Merck & Co., Inc.

The vaccine was introduced in 2006 to protect girls and young women against four strains of the human papillomavirus (HPV). They are strains 6 and 11, which cause genital warts, and strains16 and 18, which cause the development of approximately 70 percent of cervical cancers.

Currently the vaccine has been administered to over 7 million girls and young women nationally. Gardasil garnered sales in the United States, during the first half of fiscal 2009, of $363 million. As pointed out in a New York Times article about the STD vaccine market, health analyst Tim Anderson of the New York firm Sanford C. Bernstein, (which provides research for investors) forecast that in 2015, Gardasil would own 65 percent of an estimated 3.7–billion–dollar worldwide market for the HPV vaccine. Competitor GlaxoSmithKline (GSK), which is offering Cervarix, will make up the balance.

When I first started looking at the HPV vaccine, I didn’t realize that the story would grow exponentially, touching on a wide range of issues. My goal is to present basic information in conjunction with various points of view. It is an evolving narrative. This past September, the FDA advisory panel recommended approving Gardasil for males ages 9 to 26 to prevent genital warts. A month later, the Harvard School of Public Health released research that inferred that the vaccine for boys would not be cost effective.

If you Google Gardasil, you get half a million hits covering a wide swath, with one element of information leading to another. Examples include an article inThe New England Journal of Medicine (6/22/06)about the effectiveness of using male condoms to reducethe risk of male-to-female transmission of HPV. Numerous links have appeared on how acetic acid (vinegar) has been used as an inexpensive and efficient way to screen for cervical cancer and HPV, particularly in poorer nations. In August 2008, Elisabeth Rosenthal wrote for the New York Times under the topic of “Money & Policy,”calling into question the line for drug companies between “what the manufacturers call education and their critics call marketing.” Lucinda Marshall, at Feminist Peace Network, has consistently been on top of the Gardasil story, and wrote for Dissident Voice about why she believed “Making the HPV Vaccine Mandatory Is Bad Medicine.”

In examining material about the Gardasil vaccine and cervical cancer, one of the points that comes up regularly is the efficacy of the Pap test for screening and detecting precancerous cells in the cervix. In the past half-century, deaths resulting from cervical cancer in America have dropped approximately 70 percent. Of the estimated 11,000 women in the country who will develop cervical cancer, almost 4,000 will die. Most of that demographichas never had a Pap smear test. The question is, why? Is there a lack of affordable health insurance? No transportation to the doctor?

I spoke with Jessica Arons from the Center for American Progress, a Washington, D.C., think tank, about these concerns. She responded by raising questions about women’s “regular access to the current healthcare system.” When the Gardasil vaccine was first approved by the FDA, her organization was generally supportive. However, she referenced the issue of “cost and allocation of resources,” and queried if it would be more effective to target the population for a three-part vaccine (which presents its own set of logistical and economic barriers) or to improve overall access to the healthcare system (which would allow for routine screening…and treatment when necessary).

Arons addressed the impediments brought on by expense and other hurdles caused by the current mandate from the Immigration and Naturalization Services, requiring all females from the age of 11–26 who are seeking legal entry to the United States to get the HPV vaccine. Arons explained that the high cost of the vaccine might be prohibitive to female immigrants and their families, and the vaccine may not be available in their country of origin. In addition, the mandate deprives those seeking a green card of the right to independently decide whether this vaccine is right for them. Currently, HPV is not an imminent public–health threat.

Aware of the accusations against Merck for an overly aggressive marketing campaign, Arons commented, “Merck certainly has the right to participate in the government process, but it is important to have watchdog groups involved as well, to ensure that monied interests do not overwhelm the process and that women’s health remains the overriding priority.”